TY - JOUR
T1 - Previous Surgery and Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
AU - Kezirian, Eric J.
AU - Heiser, Clemens
AU - Steffen, Armin
AU - Boon, Maurits
AU - Hofauer, Benedikt
AU - Doghramji, Karl
AU - Maurer, Joachim T.
AU - Sommer, J. Ulrich
AU - Soose, Ryan J.
AU - Schwab, Richard
AU - Thaler, Erica
AU - Withrow, Kirk
AU - Kominsky, Alan
AU - Larsen, Christopher G.
AU - Hsia, Jennifer
AU - Mehra, Reena
AU - Waters, Tina
AU - Strohl, Kingman
N1 - Funding Information:
The ADHERE Registry was supported by Inspire Medical Systems, Inc. There was no specific support for the performance or study design of these analyses. Inspire Medical Systems, Inc personnel did not participate in the writing or revision of this manuscript.
Funding Information:
Systems—research funding; Pillar Palatal, Nyxoah, Split Rock Scientific, Gerard Scientific, Berendo Scientific—scientific advisory board, consultant; Magnap—intellectual property rights; Clemens Heiser, Inspire Medical Systems—consultant; Armin Steffen, Inspire Medical Systems—reimbursement of conference fees, travel/accommodation expenses, conducting studies, funding for research he himself initiated, consultant; Merz—advisory board, consultant, reimbursement of travel fees; Intersect—grants for invited talks; Maurits Boon, Inspire Medical Systems—honoraria, research support; Benedikt Hofauer, Inspire Medical Systems—compensation of travel costs and congress fees; Karl Doghramji, Inspire Medical Systems—consultant, research support; Joachim T. Maurer, Inspire Medical Systems—consultant, surgical trainer, invited speaker; Nyxoah—consultant; Revent, ImThera—invited speaker; J. Ulrich Sommer, Inspire Medical Systems—research funding, grants, consultant, and speaker honoraria; Ryan J. Soose, Inspire Medical Systems—consultant, trial investigator; Galvani Bioelectrics, Invicta Medical, CryOSA—consultant; Richard Schwab, Inspire Medical Systems—grant for registry and postapproval study; Erica Thaler, Inspire Medical Systems—grant funding, consultant; Christopher G. Larsen, Inspire Medical Systems—consultant; Reena Mehra, Inspire Medical Systems—research grant; Tina Waters, Inspire Medical Systems— study site (Cleveland Clinic) physician investigator for the Inspire ADHERE registry. Dr. Waters’s institution receives funds from Inspire, Inc for conduct of research; Kingman Strohl, Inspire Medical Systems—site, principal investigator postapproval study.
Publisher Copyright:
© American Academy of Otolaryngology–Head and Neck Surgery Foundation 2019.
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2019/11/1
Y1 - 2019/11/1
N2 - Objective: To examine whether previous palate or hypopharyngeal surgery was associated with efficacy of treatment of obstructive sleep apnea with hypoglossal nerve stimulation. Study Design: Cohort (retrospective and prospective). Setting: Eleven academic medical centers. Subjects and Methods: Adults treated with hypoglossal nerve stimulation were enrolled in the ADHERE Registry. Outcomes were defined by the apnea-hypopnea index (AHI), in 3 ways: change in the AHI and 2 definitions of therapy response requiring ≥50% reduction in the AHI to a level <20 events/h (Response20) or 15 events/h (Response15). Previous palate and hypopharyngeal (tongue, epiglottis, or maxillofacial) procedures were documented. Linear and logistic regression examined the association between previous palate or hypopharyngeal surgery and outcomes, with adjustment for age, sex, and body mass index. Results: The majority (73%, 217 of 299) had no previous palate or hypopharyngeal surgery, while 25% and 9% had previous palate or hypopharyngeal surgery, respectively, including 6% with previous palate and hypopharyngeal surgery. Baseline AHI (36.0 ± 15.6 events/h) decreased to 12.0 ± 13.3 at therapy titration (P <.001) and 11.4 ± 12.6 at final follow-up (P <.001). Any previous surgery, previous palate surgery, and previous hypopharyngeal surgery were not clearly associated with treatment response; for example, any previous surgery was associated with a 0.69 (95% CI: 0.37, 1.27) odds of response (Response20 measure) at therapy titration and a 0.55 (95% CI: 0.22, 1.34) odds of response (Response20 measure) at final follow-up. Conclusion: Previous upper airway surgery was not clearly associated with efficacy of hypoglossal nerve stimulation.
AB - Objective: To examine whether previous palate or hypopharyngeal surgery was associated with efficacy of treatment of obstructive sleep apnea with hypoglossal nerve stimulation. Study Design: Cohort (retrospective and prospective). Setting: Eleven academic medical centers. Subjects and Methods: Adults treated with hypoglossal nerve stimulation were enrolled in the ADHERE Registry. Outcomes were defined by the apnea-hypopnea index (AHI), in 3 ways: change in the AHI and 2 definitions of therapy response requiring ≥50% reduction in the AHI to a level <20 events/h (Response20) or 15 events/h (Response15). Previous palate and hypopharyngeal (tongue, epiglottis, or maxillofacial) procedures were documented. Linear and logistic regression examined the association between previous palate or hypopharyngeal surgery and outcomes, with adjustment for age, sex, and body mass index. Results: The majority (73%, 217 of 299) had no previous palate or hypopharyngeal surgery, while 25% and 9% had previous palate or hypopharyngeal surgery, respectively, including 6% with previous palate and hypopharyngeal surgery. Baseline AHI (36.0 ± 15.6 events/h) decreased to 12.0 ± 13.3 at therapy titration (P <.001) and 11.4 ± 12.6 at final follow-up (P <.001). Any previous surgery, previous palate surgery, and previous hypopharyngeal surgery were not clearly associated with treatment response; for example, any previous surgery was associated with a 0.69 (95% CI: 0.37, 1.27) odds of response (Response20 measure) at therapy titration and a 0.55 (95% CI: 0.22, 1.34) odds of response (Response20 measure) at final follow-up. Conclusion: Previous upper airway surgery was not clearly associated with efficacy of hypoglossal nerve stimulation.
UR - http://www.scopus.com/inward/record.url?scp=85068340596&partnerID=8YFLogxK
U2 - 10.1177/0194599819856339
DO - 10.1177/0194599819856339
M3 - Journal articles
C2 - 31234734
AN - SCOPUS:85068340596
SN - 0194-5998
VL - 161
SP - 897
EP - 903
JO - Otolaryngology - Head and Neck Surgery (United States)
JF - Otolaryngology - Head and Neck Surgery (United States)
IS - 5
ER -